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Pharmaceutical Research & Consulting

Helping clients navigate FDA and Health Canada regulations since 2002

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The dicentra advantage

Our interdisciplinary pharmaceutical team has combined experience in drug applications and submissions, quality management, regulatory compliance, and clinical trials

Our Pharmaceutical Services

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Drug Applications & Submissions

  • New Drug Applications (NDA) including 505(b)(1) & 505(b)(2) applications
  • Abbreviated new drug applications (ANDA) and supplemental new drug applications (SNDA)
  • Investigational New Drug (IND) applications
  • Drug Establishment Registration and Labellor code request
  • Over-the-counter (OTC) Drug Product Registration
  • New Drug Submission (NDS)
  • Abbreviated New Drug Submission (ANDS) and Supplement to a New Drug Submission (SNDS)
  • Drug Identification Number (DIN) application
  • Drug Establishment Licence (DEL)
  • Non-Prescription (OTC) drug registration
  • Non-prescription drug monograph attestation
  • Prescription to OTC Switch (Rx to OTC)
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Quality Systems Compliance Services

  • Good Manufacturing Practice (GMP) Services
  • Good Laboratory Practice (GLP) Services
  • Good Clinical Practice (GCP) Services
  • Strategy and risk analysis
  • QMS design and development
  • QMS audit and assessment against FDA 21 CFR Part 201
  • QMS audit and assessment against Part C, Division 2 of Canada’s Food and Drug Regulations
  • QMS verification and improvement
  • SOP & PnP preparation and review
  • Third-party CGMP Audit
  • Quality system training
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Regulatory Compliance

  • Drug classification (monograph vs. new drug; prescription vs. non-prescription)
  • Determine whether your product meets Generally Recognized as Safe and Effective (GRASE) conditions
  • Changes Being Effected (CBE) filing, Changes Being Effected in 30 days (CBE 30) filing
  • Annual Report preparation
  • Prior Approval Supplement (PAS)
  • Notifiable Change (NC) & Notice of Compliance (NOC)
  • Major change, moderate change, minor change reporting
  • Annual Drug Notification Form (ADNF) preparation
  • Drug Labelling
  • Adverse event reporting/Adverse reaction reporting
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Clinical Trials

  • Pre-clinical trials
  • Pharmacokinetics/Pharmacodynamics (Pk/Pd)
  • Bioequivalence studies
  • Recruitment
  • Phase I/IIa Clinical Trials
  • Phase II/III Clinical Trials
  • Phase IV/Post marketing surveillance
  • Pharmacovigilance
  • Biostatistics

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